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临床试验/NCT02868151
NCT02868151已完成2 期

Effect of Ascorbic Acid Oral Supplementation in Assessing the Severity of Oral Mucositis in Chemo-radiation Therapy of Head and Neck Cancers.

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
180
试验地点
1
主要终点
World Health Organization criteria of grading oral mucositis.for head and neck cancer patients

研究概览

简要总结

The surrounding controversies both advocating and simultaneously opposing the use of vitamin C, mostly extrapolating animal models to human models, it has not been used individually to assess the severity of oral mucositis during chemoradiotherapy.

The present study is undertaken to evaluate the effect of vitamin C oral supplements in assessing the severity of oral mucositis during chemoradiotherapy for oral cancer.

详细描述

Oral mucositis is a predictable and unavoidable representation during the course of radiotherapy employed for treatment of head and neck cancers. The term oral mucositis is used to describe inflammation of the oral mucosa, a separate entity distinct from oral lesions with other pathogenic background generally summarized as stomatitis. The cells that line the gastrointestinal tract from the mouth to the rectum are especially vulnerable to such changes. The incidence and severity of oral mucositis is influenced by the type of antineoplastic treatment administered and patient related factors. The pathogenesis of radiation mucositis though not completely understood, is usually either by direct DNA damage or via an indirect mechanism of releasing free radicals upon radiolysis of water effecting the oral epithelium.It is associated with significant morbidity, pain, odynophagia, malnutrition thereby affecting the overall quality of life in these patients and carrying a more important risk of systemic infections particularly in impaired host defense setup.In addition to acute damage wide range of GI mucosal involvement occurs during radiotherapy.

Various radiation modifying agents have been used which can either selectively protect normal cells but not tumor cells against therapeutic damage or can selectively enhance the effect of radiation on tumor cells but not on normal cells thereby improving efficacy of radiation therapy. In spite of extensive research most of them are found to be toxic.

Antioxidants represent most selective radiation modifying agents that are non toxic to humans. However, because of many conflicting hypothesis on their usage affecting tumor response and also decreasing the radiation induced toxicity on normal cells, recommendations have followed for their non usage during chemo-radiotherapy. In spite of such reservations on behalf of oncologists over 70% of patients are on antioxidant supplements such as those containing vitamin A, vitamin C and polar carotenoids with or without the knowledge of oncologists.

Antioxidants can neutralize those free radicals generated during radio-chemo therapy enhancing body's antioxidant stores in order to prevent mucositis and to maintain healthy oral tissues. Literature survey provides exhaustive list of such antioxidants successfully implicated in controlling oral mucositis to some extent. Antioxidants such as beta carotene, vitamin E and vitamin C in combination, glutamine, glutathione have been studied.

Vitamin C is a water soluble nutrient that has wide antioxidant and wound healing properties. It has been widely in scurvy patients but its effect on conventional cancer therapy by radiation and chemotherapy were little known. Limited preclinical data suggested that this vitamin at high concentrations increased the toxicity of certain chemotherapeutic drugs in animals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who are attending Mehdi Nawaz Jung cancer hospital for radiotherapy and who provide written consent for the study.

排除标准

  • Patients with known allergy to vitamin C
  • Patients with Glucose-6-phosphate dehydrogenase deficiency
  • Patients with renal failure

研究组 & 干预措施

GROUP B

Experimental

Ascorbic acid oral supplementation 1g four times daily for the entire treatment period of 30 days and after treatment by tapering the dose of the drug to half for another month. The drug has to be started 2 days prior to initiation of treatment of cancer.

Subdivided into 2 groups , 30 patients in each : sub group 1: only radiotherapy patients, subgroup 2 includes concurrent chemo-radiotherapy patients.

干预措施: Ascorbic Acid (Drug)

GROUP C

Experimental

Zinc acetate tablets 50mg orally

干预措施: Zinc acetate (Drug)

结局指标

主要结局

World Health Organization criteria of grading oral mucositis.for head and neck cancer patients

时间窗: one and half years.

oral mucositis severity would be measured weekly in all the patients during the entire treatment of radiotherapy/chemotherapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NALLAN CHAITANYA

Associate Professor, department of oral medicine and radiology, panineeya institute of dental sciences

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

研究点 (1)

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